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FDA gives greenlight to first digital ingestion tracking system

Abilify MyCite, developed in collaboration between Proteus Digital Health and Otsuka Pharmaceutical, has an ingestible sensor embedded in the pill which records that the medication was taken. It reflects a trend by companies to use sensors to quantify the effectiveness of medications.

The U.S. Food and Drug Administration approved a joint application by Proteus Digital Health and Otsuka Pharmaceutical for a medication monitoring tool for patients taking Otsuka’s drug Abilify. The drug is geared for people with schizophrenia, bipolar disorder and in some cases, depression.

Sensors, developed by Proteus Digital Health, are embedded in the pills and activated by stomach juices. The sensor transmits signals to a wearable with an electrode in the form of a skin patch. Data such as vital signs, body position, and verification of medication ingestion are wirelessly transmitted with the help of the wearable.

The FDA approval came with some caveats regarding the technology’s limitations, though. It noted that the ability of the sensors to track the patient’s compliance with their treatment regimen “has not been shown”.

“Abilify MyCite should not be used to track drug ingestion in ‘real-time’ or during an emergency because detection may be delayed or may not occur,” the FDA news release said.

The approval for the pill monitoring platform came six months after Proteus and Otsuka had submitted a joint NDA for the second time after the regulator requested the companies to work out some issues in a complete response letter.

The ingestible sensor used in Abilify MyCite was cleared for marketing by the FDA in 2012. Abilify was approved ten years earlier.

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A Deep-dive Into Specialty Pharma

A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.

The FDA approval for the joint submission clears the way for joint submissions by other pharma companies. Longterm, the Proteus platform could be used to tailor medicines more closely to reflect each of person’s medication-taking patterns and lifestyle choices.

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